Genpact, a global leader in advanced technology services and AI-powered business solutions, is inviting applications for the position of Specialist – Regulatory Affairs Operations. This is an excellent opportunity for B.Pharm, B.Sc Chemistry, Healthcare, Public Health, and Regulatory Affairs professionals with 3–7 years of experience in regulatory publishing, eCTD submissions, and regulatory operations.
The vacancies are available across Mumbai, Hyderabad, and Delhi NCR (Gurgaon/Noida) with flexible shift timings. Candidates with expertise in ICH Guidelines, CTD Structure, eCTD Publishing, Liquent, and DocuBridge are encouraged to apply.
Job Highlights
- Company: Genpact
- Position: Specialist – Regulatory Affairs Operations
- Job Type: Full-Time, Permanent
- Experience: 3–7 Years
- Location: Mumbai, Hyderabad, Delhi NCR (Gurgaon/Noida)
- Openings: 4
- Salary: ₹8 – ₹14 LPA (Estimated)
- Shift: Flexible
About Genpact
Genpact (NYSE: G) is a global professional services company specializing in digital transformation, AI, analytics, and business process management. With over 140,000 professionals worldwide, Genpact helps leading enterprises improve operational efficiency through innovation, automation, and advanced technology solutions.
The company offers excellent career growth opportunities, continuous learning programs, and exposure to global pharmaceutical and healthcare regulatory operations.
Key Responsibilities
As a Specialist – Regulatory Affairs Operations, you will be responsible for:
- Publishing and performing technical validation of eCTD submissions for the US market.
- Executing final technical quality review of regulatory dossiers.
- Dispatching submissions to health authorities in eCTD, CTD, NeeS, and Paper formats.
- Managing post-submission activities including acknowledgements and metadata capture.
- Uploading and maintaining regulatory correspondence in RIM systems.
- Coordinating with global stakeholders to ensure successful submission delivery.
- Ensuring compliance with regulatory standards and internal quality procedures.
- Working with publishing tools including Liquent, DocuBridge, and similar platforms.
Required Qualifications
Candidates should possess any of the following qualifications:
- Bachelor in Pharmacy (B.Pharm)
- Bachelor in Healthcare
- Bachelor in Health Administration
- B.Sc Chemistry
- Master’s in Public Health (MPH)
- Master’s in Regulatory Affairs
Required Skills
Preferred candidates should have experience in:
- Regulatory Affairs Operations
- eCTD Publishing
- Electronic Submissions
- ICH Guidelines
- CTD Structure
- NeeS Submissions
- US Regulatory Submissions
- Technical Validation
- Regulatory Documentation
- RIM Systems
- Liquent
- DocuBridge
- Submission Publishing
- Regulatory Compliance
- Pharmaceutical Regulatory Affairs
Why Join Genpact?
Working at Genpact offers numerous career advantages:
- Opportunity to work on cutting-edge AI and digital transformation projects.
- Exposure to global pharmaceutical regulatory operations.
- Career advancement through structured learning and mentorship.
- Collaborative work culture with international teams.
- Flexible work shifts.
- Inclusive and diverse workplace.
- Opportunity to work with one of the world’s leading technology and business services companies.
Job Location
- Mumbai
- Hyderabad
- Delhi NCR (Gurgaon)
- Delhi NCR (Noida)
Estimated Salary
Based on similar Regulatory Affairs roles in India, the expected salary ranges between:
₹8,00,000 – ₹14,00,000 per annum
(Actual compensation depends on experience, skills, and interview performance.)